1 of 11

Regulatory and Ethics Work Stream

Lead: Professor Bartha Maria Knoppers

Lead: Professor Madeleine Murtagh

Manager: Adrian Thorogood

ga4gh.org

2 of 11

GA4GH Framework for Responsible Sharing of Genomic and Health-Related Data

“Everyone has the right … to share in scientific advancement and its benefits.”

(Universal Declaration of Human Rights art 27(1))

2

ga4gh.org

Dual rights rendered legally binding by the International Covenant on Economic, Social and Cultural Rights (ICESCR) (1966) – Article 15.

Ratified by 164 States.

States are bound to implement in national law.

Contours of responsible access, sharing, and attribution delineated by other human rights:
privacy;
anti-discrimination and fair access; and
procedural fairness.

(Genetic) Research ethics: experimental research on human subjects (or identifiable samples and data):

respect participant’s rights and interests (welfare, autonomy (free and informed consent and withdrawal), privacy, confidentiality). (WMA DoH; UNESCO, Universal Declaration on Bioethics and Human Rights, 2005)

Information governance: “we are witnessing a shift from rights-based approach to the adjudication of competing claims, in which benefits to the economy, for example, are seen as goods to be balanced with a data subject’s right to privacy and confidentiality.” (Hockings, E. (2016))

Data sharing policy: maximize utility of data; improve speed, accuracy, transparency and quality of research findings; avoid duplication of effort and waste of public resources. (NIH, GDS)
Public policy: Improving health, the economy, and advancing science.
Human rights: Right of everyone to benefit from scientific advancement and its applications.
Ethics of inclusion: vulnerable and under-represented.

Public deliberation: Sectoral interests dominate deliberation / Long term public and regulatory backlash! (think GMOs…Schrems/GDPR...)

United Nations Educational Social Cultural Organisation. 2005. Universal Declaration on Bioethics and Human Rights. http://unesdoc.unesco.org/images/0014/001461/146180E.pdf. Accessed 27 Feb 2015.

Article 5 Autonomy and individual responsibility The autonomy of persons to make decisions, while taking responsibility for those decisions and respecting the autonomy of others, is to be respected. For persons who are not capable of exercising autonomy, special measures are to be taken to protect their rights and interests.

Article 6 Consent 1. Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice. 2. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. Consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice.

Hockings, E. (2016). A critical examination of policy-developments in information governance and the biosciences. In The ethics of biomedical big data (pp. 95-115). Springer, Cham.)

3 of 11

Framework - Human Rights Foundation

Universal Declaration of Human Rights, (1948)

“The Right to Science”

“Everyone has the right to

the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.”

“Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits.”

27(1)

27(2)

“The Right to Recognition”

ga4gh.org

4 of 11

REWS Toolkit

4

Consent Policy
Template/Clauses
Consent Codes
Access and Discovery Matrix
Registered Access

Privacy & Security
Lexicon
Accountability
Ethics Review Equivalency

Framework for Responsible Sharing of Genomic and Health-Related Data

genomicsandhealth.org

5 of 11

Regulatory&Ethics Self-Assessment: GA4GH Products

Processing of personal data?
Data subject consents or other legal agreements needed?
Some form of review, approval or oversight needed?
Intellectual property implications?
Enables blocking of access to data?
Affects clinical decision making by health professionals or patients?
Perpetuates disadvantage or inequalities?

5

ga4gh.org

6 of 11

'Your DNA, Your Say'

Global online survey gathering public attitudes towards genomic data sharing using approachable, innovative films.

ga4gh.org

7 of 11

USA

UK

Australia

Canada

Russia

India

Spain

Mexico

Costa Rica

Brazil

Portugal

France

Germany

South

Africa

Japan

China

Saudi

Arabia

Italy

Poland

Iceland

Sweden

Austria

Chile

Currently available

Coming soon

Egypt

Sudan

Belgium

Switzerland

8 of 11

8

Subscribe to our monthly briefs: https://goo.gl/CbQP6x
Read the introductory Primer: http://goo.gl/aPQ8iM

GA4GH GDPR and International Health Data Sharing Forum

ga4gh.org

As way of background info, here’s the procedure for constructing the monthly GDPR Briefs, which start this month in October:

1. Each editor (i.e. lead author) shall circulate a draft GDPR Brief to Ted and(/or) Mark for comment by mid-way point of the month preceding publication.

2. Ted and(/or) Mark will then provide comments on the draft brief within 3 working business days.

3. The editor will then revise the draft brief within 3 working business days and send it to Ted.

4. Ted will then circulate the draft brief to the GDPR Forum, who as a whole will have up to 5 working business days to provide comments.

5. The editor will be responsible for collating comments and integrating them into the draft GDPR Brief.

6. A final version of the GDPR Brief shall be completed by penultimate day of each of month (provided it is a working business day), and shall then be sent to Ted to have it disseminated as a newsletter no later than the first business day of the next month.

9 of 11

About the Forum

Launched in August 2018 as part of the REWS

Purpose is to discuss and disseminate information regarding European data protection law – specifically the EU General Data Protection Regulation (GDPR) 2016/679 – and its impact on international genomic and health-related data sharing

‘GDPR Primer’ on the law’s impact on international genomic and health-related data sharing, drafted in August and released in September 2018.

Monthly one-page GDPR Briefs, provide concise and timely guidance on specific topics to health researchers, institutions, ethics bodies, and data sharing initiatives internationally.

9

genomicsandhealth.org

10 of 11

GDPR Primer – September 2018

Highlights ten key areas of the GDPR that affect int’l health research and data sharing:

Territorial scope
Transparency and accountability
“Data protection by design” and data protection impact assessments
Data protection impact assessments
Data Protection Officers
Consent
Processing special categories of data
Data subject rights derogations
Secondary use
International data transfer

Primer also suggests ‘further resources to consult’ if readers would like more information on the GDPR and its impact on international health research and data sharing

10

genomicsandhealth.org

11 of 11

Forum members

Edward Dove (Chair/Co-Editor)
Mark Phillips (Co-Editor)
David Townend
Robert Eiss
Laura Rodriguez

Ruth Boardman
Fruzsina Molnar-Gabor
Jasper Bovenberg
Alison Hall
Anne-Marie Tassé

11

Dixie Baker
Johan Ordish
Yongxi Chen
Mark Taylor

genomicsandhealth.org